Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02026349




Registration number
NCT02026349
Ethics application status
Date submitted
19/12/2013
Date registered
3/01/2014
Date last updated
11/11/2015

Titles & IDs
Public title
Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza (T705US316)
Secondary ID [1] 0 0
2013-002149-13
Secondary ID [2] 0 0
T705US316
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - favipiravir
Treatment: Drugs - Placebo

Active comparator: favipiravir -

Placebo comparator: placebo -


Treatment: Drugs: favipiravir
Administered twice daily over 5 consecutive days for a total of 10 doses.

* Day 1: 1800 mg twice daily (loading doses)
* Days 2 through 5: 800 mg twice daily

Treatment: Drugs: Placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to alleviation of all primary influenza symptoms and fever
Timepoint [1] 0 0
21 days
Secondary outcome [1] 0 0
Time to alleviation each of the primary influenza symptoms and fever
Timepoint [1] 0 0
21 days
Secondary outcome [2] 0 0
To characterize the PK of favipiravir when used under clinical conditions
Timepoint [2] 0 0
21 days

Eligibility
Key inclusion criteria
* At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue
* Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as: = 38.0°C (= 100.4°F) if < 65 years old; or = 37.8°C (= 100.0°F) if = 65 years old
* Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
* Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
* Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
* Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
* Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
* Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
* Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
* Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
* Has an allergy or contraindication to use of acetaminophen (paracetamol)
* Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen > 1 year), or is deemed by the Investigator to be ineligible for any reason
* Previously participated in a clinical trial of favipiravir (T-705)
* Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
860
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment postcode(s) [1] 0 0
05042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Belgium
State/province [20] 0 0
Antwerpen
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Hainaut
Country [23] 0 0
Belgium
State/province [23] 0 0
Limburg
Country [24] 0 0
Belgium
State/province [24] 0 0
Liège
Country [25] 0 0
Belgium
State/province [25] 0 0
Deurne
Country [26] 0 0
Belgium
State/province [26] 0 0
Gribomont
Country [27] 0 0
Belgium
State/province [27] 0 0
Linkebeek
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia-Grad
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Burgas
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Gabrovo
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Haskovo
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Plovdiv
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Ruse
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Samokov
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Sevlievo
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Sliven
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Smolyan
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Varna
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Veliko Tarnovo
Country [41] 0 0
Hungary
State/province [41] 0 0
Balassagyarmat
Country [42] 0 0
Hungary
State/province [42] 0 0
Budapest
Country [43] 0 0
Hungary
State/province [43] 0 0
Csongrad
Country [44] 0 0
Hungary
State/province [44] 0 0
Debrecen
Country [45] 0 0
Hungary
State/province [45] 0 0
Gyula
Country [46] 0 0
Hungary
State/province [46] 0 0
Gödöllo
Country [47] 0 0
Hungary
State/province [47] 0 0
Nyiregyhaza
Country [48] 0 0
Hungary
State/province [48] 0 0
Zalaegerszeg
Country [49] 0 0
Netherlands
State/province [49] 0 0
Overijssel
Country [50] 0 0
Netherlands
State/province [50] 0 0
Overissel
Country [51] 0 0
Netherlands
State/province [51] 0 0
Zuid-Holland
Country [52] 0 0
Netherlands
State/province [52] 0 0
Den Haag
Country [53] 0 0
Netherlands
State/province [53] 0 0
Lieshout
Country [54] 0 0
Netherlands
State/province [54] 0 0
Nijverdal
Country [55] 0 0
Netherlands
State/province [55] 0 0
Rotterdam
Country [56] 0 0
Netherlands
State/province [56] 0 0
Zwijndrecht
Country [57] 0 0
New Zealand
State/province [57] 0 0
North Island
Country [58] 0 0
New Zealand
State/province [58] 0 0
South Island
Country [59] 0 0
New Zealand
State/province [59] 0 0
Waikato
Country [60] 0 0
New Zealand
State/province [60] 0 0
Tauranga
Country [61] 0 0
Poland
State/province [61] 0 0
Dolnoslaskie
Country [62] 0 0
Poland
State/province [62] 0 0
Kujawsko-pomorskie
Country [63] 0 0
Poland
State/province [63] 0 0
Lubelskie
Country [64] 0 0
Poland
State/province [64] 0 0
Lódzkie
Country [65] 0 0
Poland
State/province [65] 0 0
Malopolskie
Country [66] 0 0
Poland
State/province [66] 0 0
Mazowieckie
Country [67] 0 0
Poland
State/province [67] 0 0
Podkarpackie
Country [68] 0 0
Poland
State/province [68] 0 0
Slaskie
Country [69] 0 0
Poland
State/province [69] 0 0
Katowice
Country [70] 0 0
Poland
State/province [70] 0 0
Krakow
Country [71] 0 0
Poland
State/province [71] 0 0
Kraków
Country [72] 0 0
Poland
State/province [72] 0 0
Lódz
Country [73] 0 0
Poland
State/province [73] 0 0
Ostroda
Country [74] 0 0
Poland
State/province [74] 0 0
Oswiecim
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Arkangelsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Kazan
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Moscow
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Novosibirsk
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Ryazan
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Saratov
Country [81] 0 0
Russian Federation
State/province [81] 0 0
St. Petersburg
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Tomsk
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Vladimir
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Yaroslavl
Country [85] 0 0
South Africa
State/province [85] 0 0
Free State
Country [86] 0 0
South Africa
State/province [86] 0 0
Gauteng
Country [87] 0 0
South Africa
State/province [87] 0 0
Kwazulu - Natal
Country [88] 0 0
South Africa
State/province [88] 0 0
Mpumalanga
Country [89] 0 0
South Africa
State/province [89] 0 0
Western Cape
Country [90] 0 0
South Africa
State/province [90] 0 0
Cape Town
Country [91] 0 0
South Africa
State/province [91] 0 0
Durban
Country [92] 0 0
South Africa
State/province [92] 0 0
Johannesburg
Country [93] 0 0
South Africa
State/province [93] 0 0
Krugersdorp
Country [94] 0 0
South Africa
State/province [94] 0 0
Potchefstroom
Country [95] 0 0
South Africa
State/province [95] 0 0
Pretoria
Country [96] 0 0
South Africa
State/province [96] 0 0
Sophiatown, Johannesburg
Country [97] 0 0
South Africa
State/province [97] 0 0
Umkomaas
Country [98] 0 0
South Africa
State/province [98] 0 0
Welkom
Country [99] 0 0
Spain
State/province [99] 0 0
Alicante
Country [100] 0 0
Spain
State/province [100] 0 0
Barcelona
Country [101] 0 0
Spain
State/province [101] 0 0
Castellón
Country [102] 0 0
Spain
State/province [102] 0 0
Cataluña
Country [103] 0 0
Spain
State/province [103] 0 0
Girona
Country [104] 0 0
Spain
State/province [104] 0 0
Tarragona
Country [105] 0 0
Sweden
State/province [105] 0 0
Skane lan
Country [106] 0 0
Sweden
State/province [106] 0 0
Sodermanlands lan
Country [107] 0 0
Sweden
State/province [107] 0 0
Uppsala Ian
Country [108] 0 0
Sweden
State/province [108] 0 0
Vastra Gotalands lan
Country [109] 0 0
Sweden
State/province [109] 0 0
Karlskrona
Country [110] 0 0
Sweden
State/province [110] 0 0
Linköping
Country [111] 0 0
Sweden
State/province [111] 0 0
Malmö
Country [112] 0 0
Sweden
State/province [112] 0 0
Uppsala
Country [113] 0 0
Turkey
State/province [113] 0 0
Ankara
Country [114] 0 0
Turkey
State/province [114] 0 0
Diyarbakir
Country [115] 0 0
Turkey
State/province [115] 0 0
Duzce
Country [116] 0 0
Turkey
State/province [116] 0 0
Erzurum
Country [117] 0 0
Turkey
State/province [117] 0 0
Eskisehir
Country [118] 0 0
Turkey
State/province [118] 0 0
Izmir
Country [119] 0 0
Turkey
State/province [119] 0 0
Konya
Country [120] 0 0
Turkey
State/province [120] 0 0
Samsun
Country [121] 0 0
Turkey
State/province [121] 0 0
Trabzon
Country [122] 0 0
Ukraine
State/province [122] 0 0
Chernivets'ka Oblast
Country [123] 0 0
Ukraine
State/province [123] 0 0
Ivano-Frankivs'ka Oblast
Country [124] 0 0
Ukraine
State/province [124] 0 0
Kharkivs'ka Oblast
Country [125] 0 0
Ukraine
State/province [125] 0 0
Kyïvs'ka Oblast
Country [126] 0 0
Ukraine
State/province [126] 0 0
Kyïv
Country [127] 0 0
Ukraine
State/province [127] 0 0
Odes'ka Oblast
Country [128] 0 0
Ukraine
State/province [128] 0 0
Ternopil's'ka Oblast
Country [129] 0 0
Ukraine
State/province [129] 0 0
Vinnyts'ka Oblast
Country [130] 0 0
Ukraine
State/province [130] 0 0
Kharkiv
Country [131] 0 0
Ukraine
State/province [131] 0 0
Kherson
Country [132] 0 0
Ukraine
State/province [132] 0 0
Kyiv
Country [133] 0 0
Ukraine
State/province [133] 0 0
Poltava
Country [134] 0 0
Ukraine
State/province [134] 0 0
Sumy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MDVI, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
MediVector, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Epstein, MD
Address 0 0
MediVector, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02026349